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The effect of cyclobenzaprine therapy on the recovery of daily activities and work capacity in patients with non-specific back and neck pain in real-world clinical practice

https://doi.org/10.14412/2074-2711-2026-4-50-57

Abstract

Objective: to assess the impact of cyclobenzaprine therapy in real-world clinical practice on the severity of pain, functional capacity and the time taken to return to work in patients with non-specific back and neck pain, as well as to evaluate the drug's safety profile.

Material and methods. The multicentre study included 997 patients (full analysis set, FAS) aged 18 years or older, of whom 976 completed the study according to protocol – per-protocol (PP) population. Patients received Reloprim (cyclobenzaprine) at a dose of 5, 7.5 or 10 mg three times daily for up to 14 days. The primary endpoint was the change in functional limitations as assessed by the Roland–Morris Disability Questionnaire (RMDQ).

Results. The baseline RMDQ score was 12.52±5.57. By day 5, it had decreased significantly to 7.18±4.53, and by the end of the study to 1.89±2.42 (p<0.001). Pain intensity (baseline 6.79±1.46 points) decreased by 2.98±1.3 points by day 5 and by 5.85±1.72 points by the end of the observation period (p<0.001). The number of patients temporarily unable to work was reduced by almost half (from 10.75 to 5.94). The need for additional doses of non-steroidal anti-inflammatory drugs (NSAIDs) was reduced by more than half.

Conclusion. The use of cyclobenzaprine as part of a comprehensive treatment regimen for non-specific back and neck pain in real-world clinical practice is associated with a statistically significant reduction in the severity of pain and functional limitations as early as the first few days of treatment, with the effect continuing to improve by the end of the observation period.

About the Authors

D. O. Rozhkov
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

Dmitry Olegovich Rozhkov

18, Trubetskaya St., Build. 2, Moscow 119048



P. M. Asadullaeva
Relaxmedica Medical Center LLC
Russian Federation

224B, Moskovsky Prosp., St. Petersburg 196066



O. V. Burenkova
Consultative and Diagnostic Polyclinic No. 27
Russian Federation

4, Relsovaya St., Novosibirsk 630105



Yu. M. Vorontsova
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

18, Trubetskaya St., Build. 2, Moscow 119048



V. V. Galkin
KDV LLC
Russian Federation

31, Vishnevaya St., Sochi 354003



M. N. Dadasheva
Family Clinic-NM LLC
Russian Federation

23, Bolshaya Pokrovskaya St., Pavlovsky Posad 142500



I. A. Zhukova
Nebbiolo LLC
Russian Federation

23, Nikolaya Ostrovskogo Lane, Tomsk 634009



N. G. Zhukova
Nebbiolo LLC
Russian Federation

23, Nikolaya Ostrovskogo Lane, Tomsk 634009



K. S. Manko
Akrikhin JSC
Russian Federation

29, Kirova St., Staraya Kupavna 142450



D. V. Milchakov
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Russian Federation

18, Trubetskaya St., Build. 2, Moscow 119048



E. B. Natarova
Voronezh City Clinical Polyclinic No. 7
Russian Federation

1, Pisatelya Marshaka St., Voronezh 394051



D. V. Semenchenko
City Hospital No. 3
Russian Federation

17, Pushkina St., 2nd Zapadny Settlement, Tula 300910



V. Yu. Sokolova
Clinical Polyclinic No. 1
Russian Federation

8, Opolchenskaya St., Volgograd 400006



A. P. Solovyov
Akrikhin JSC
Russian Federation

29, Kirova St., Staraya Kupavna 142450



V. V. Sharykin
Chekhov Vascular Center LLC
Russian Federation

36A, Beregovaya St., Chekhov 142301



References

1. Freburger JK, Holmes GM, Agans RP, et al. The rising prevalence of chronic low back pain. Arch Intern Med. 2009;169(3):251-8. doi: 10.1001/archinternmed.2008.543

2. Palmer KT, Walsh K, Bendall H, et al. Back pain in Britain: comparison of two prevalence surveys at an interval of 10 years. BMJ. 2000;320(7249):1577-8. doi: 10.1136/bmj.320.7249.1577

3. Zhang C, Lv B, Yi Q, et al. Global, regional, and national burden of low back pain in working-age population from 1990 to 2021 and projections for 2050. Front Public Health. 2025;13:1559355. doi: 10.3389/fpubh.2025.1559355

4. Hartvigsen J, Hancock MJ, Kongsted A, et al; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-67. doi: 10.1016/S0140-6736(18)30480-X

5. Da C Menezes Costa L, Maher CG, Hancock MJ, et al. The prognosis of acute and persistent low-back pain: a meta-analysis. CMAJ. 2012 Aug 7;184(11):E613-24. doi: 10.1503/cmaj.111271

6. Han CS, Hancock MJ, Sharma S, et al. Low back pain of disc, sacroiliac joint, or facet joint origin: a diagnostic accuracy systematic review. EClinicalMedicine. 2023 Apr 6;59:101960. doi: 10.1016/j.eclinm.2023.101960

7. Parfenov VA, Yakhno NN, Kukushkin ML, et al. Acute nonspecific (musculoskeletal) low back pain Guidelines of the Russian Society for the Study of Pain (RSSP). Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2018;10(2):4-11 (In Russ.). doi: 10.14412/2074-2711-2018-2-4-11

8. Cao B, Xu Q, Shi Y, et al. Pathology of pain and its implications for therapeutic interventions. Signal Transduct Target Ther. 2024 Jun 8;9(1):155. doi: 10.1038/s41392-024-01845-w

9. Manca A, Cugusi L, van Tulder M, et al. Oral non-benzodiazepine muscle-relaxants for people with acute and chronic primary low back pain: a systematic review with meta-analysis. Eur Spine J. 2025 Jun;34(6):2347-66. doi: 10.1007/s00586-025-08786-0

10. Qaseem A, Wilt TJ, McLean RM, et al; for the Clinical Guidelines Committee of the American College of Physicians. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017;166:514- 30. doi: 10.7326/M16-2367

11. Oliveira CB, Maher CG, Pinto RZ, et al. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-803. doi: 10.1007/s00586-018-5673-2

12. Chou R, Deyo R, Friedly J, et al. Systemic Pharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):480-92. doi: 10.7326/M16-2458

13. Clinical guidelines “Nonspecific back pain in adults”. Ministry of Health of the Russian Federation; 2023 (updates to current versions) (In Russ.).

14. Jordan K, Dunn KM, Lewis M, Croft P. A minimal clinically important difference was derived for the Roland-Morris Disability Questionnaire for low back pain. J Clin Epidemiol. 2006;59(1):45-52. doi: 10.1016/j.jclinepi.2005.03.018

15. Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Minimal clinically important difference. Low back pain. Spine (Phila Pa 1976). 2001;25(24):3100-3. doi: 10.1097/00007632-200012150-00002

16. Borenstein DG, Korn S. Efficacy of a low-dose regimen of cyclobenzaprine hydrochloride in acute skeletal muscle spasm: results of two placebo-controlled trials. Clin Ther. 2003;25(4):1056-73. doi: 10.1016/S0149-2918(03)80067-X

17. Landy S, Altman CA, Xie F. Time to recovery in patients with acute painful musculoskeletal conditions treated with extended-release or immediate-release cyclobenzaprine. Adv Ther. 2011;28(4):295-303. doi: 10.1007/s12325-011-0008-2

18. Malanga GA, Ruoff GE, Weil AJ, et al. Cyclobenzaprine ER for muscle spasm associated with low back and neck pain: two randomized, double-blind, placebo-controlled studies of identical design. Curr Med Res Opin. 2009;25(5):1179-96. doi: 10.1185/03007990902875849

19. Coste J, Delecoeuillerie G, Cohen de Lara A, et al. Clinical course and prognostic factors in acute low back pain: an inception cohort study in primary care practice. BMJ. 1994;308(6928):577-80. doi: 10.1136/bmj.308.6928.577

20. Grotle M, Brox JI, Veierod MB, et al. Clinical course and prognostic factors in acute low back pain: patients consulting primary care for the first time. Spine (Phila Pa 1976). 2005;30(8):976-82. doi: 10.1097/01.brs.0000158972.34102.6f

21. Borenstein DG, Lacks S, Wiesel SW. Cyclobenzaprine and naproxen versus naproxen alone in the treatment of acute low back pain and muscle spasm. Clin Ther. 1990;12(2):125-31.

22. Shirokov VA, Manko KS, Terekhov NL, et al. Russian multiple-center study of efficacy and safety of cyclobenzaprine for nonspecific neck and low back pain. Russian Journal of Pain. 2024;22(1):27-33 (In Russ.). doi: 10.17116/pain20242201127

23. DiMatteo MR, Haskard KB, Williams SL. Health beliefs, disease severity, and patient adherence: a meta-analysis. Med Care. 2007;45(6):521-8. doi: 10.1097/MLR.0b013e318032937e

24. Weil AJ, Ruoff GE, Nalamachu S, et al. Efficacy and tolerability of cyclobenzaprine extended release for acute muscle spasm: a pooled analysis. Postgrad Med. 2010;122(4):158-69. doi: 10.3810/pgm.2010.07.2182


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For citations:


Rozhkov DO, Asadullaeva PM, Burenkova OV, Vorontsova YM, Galkin VV, Dadasheva MN, Zhukova IA, Zhukova NG, Manko KS, Milchakov DV, Natarova EB, Semenchenko DV, Sokolova VY, Solovyov AP, Sharykin VV. The effect of cyclobenzaprine therapy on the recovery of daily activities and work capacity in patients with non-specific back and neck pain in real-world clinical practice. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2026;18(4):50-57. (In Russ.) https://doi.org/10.14412/2074-2711-2026-4-50-57

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ISSN 2074-2711 (Print)
ISSN 2310-1342 (Online)